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Moderna to apply for emergency use authorisation for its COVID-19 vaccine in US, Europe

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After its COVID-19 vaccine candidate exhibited an efficacy of 94.1 per cent in clinical trials, US-based biotechnology firm Moderna has said that it will apply for emergency use authorisation from the US FDA. It also said it will apply for conditional approval from the European Medicines Agency.

A few weeks ago, Moderna had claimed that its vaccine had shown efficacy of 94.5 per cent in preventing COVID-19. The company’s announcement had come just a week after Pfizer and BioNtech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.

Clinical validation

The company’s CEO Stephane Bancel said, “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters.”

“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” Bancel said as the pandemic has killed more than 1.3 million people worldwide, more than 245,000 of them in the US.

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“The independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 per cent,” Moderna said in a statement.

This study, known as the COVE study, enrolled more than 30,000 participants in the US, it added.

Moderna plans around 1 billion doses in 2021

By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.

The announcements about the vaccines and their potential availability for use among the general population in the coming weeks and months have offered hope to millions around the world in a year that has seen the COVID-19 pandemic devastate lives and economies and still showing no signs of abating.

 

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